Federal Register / Vol. 84, No. 38 / Tuesday, February 26, 2019 / Rules and Regulations 6081

Dated: February 20, 2019. Docket is (703) 305–5805. Please review any Confidential Business Information K.M. Luttrell, the visitor instructions and additional (CBI)) for inclusion in the public docket. Captain, U.S. Coast Guard, Captain of the information about the docket available Information not marked confidential Port Sector New Orleans. at http://www.epa.gov/dockets. pursuant to 40 CFR part 2 may be [FR Doc. 2019–03253 Filed 2–25–19; 8:45 am] FOR FURTHER INFORMATION CONTACT: disclosed publicly by EPA without prior BILLING CODE 9110–04–P Michael Goodis, Registration Division notice. Submit the non-CBI copy of your (7505P), Office of Pesticide Programs, objection or hearing request, identified Environmental Protection Agency, 1200 by docket ID number EPA–HQ–OPP– ENVIRONMENTAL PROTECTION Pennsylvania Ave. NW, Washington, DC 2018–0032, by one of the following 20460–0001; main telephone number: methods: AGENCY • (703) 305–7090; email address: Federal eRulemaking Portal: http:// 40 CFR Part 180 [email protected]. www.regulations.gov. Follow the online instructions for submitting comments. SUPPLEMENTARY INFORMATION: [EPA–HQ–OPP–2018–0032; FRL–9987–83] Do not submit electronically any I. General Information information you consider to be CBI or and Waxy Substances, Rice other information whose disclosure is Bran, Oxidized; Exemption From the A. Does this action apply to me? restricted by statute. Requirement of a Tolerance You may be potentially affected by • Mail: OPP Docket, Environmental AGENCY: Environmental Protection this action if you are an agricultural Protection Agency Docket Center (EPA/ Agency (EPA). producer, food manufacturer, or DC), (28221T), 1200 Pennsylvania Ave. pesticide manufacturer. The following ACTION: Final rule. NW, Washington, DC 20460–0001. list of North American Industrial • Hand Delivery: To make special SUMMARY: This regulation establishes an Classification System (NAICS) codes is arrangements for hand delivery or exemption from the requirement of a not intended to be exhaustive, but rather delivery of boxed information, please tolerance for residues of waxes and provides a guide to help readers follow the instructions at http:// waxy substances, rice bran, oxidized determine whether this document www.epa.gov/dockets/contacts.html. when used as an inert ingredient in applies to them. Potentially affected Additional instructions on pesticide formulations applied to entities may include: commenting or visiting the docket, growing crops and raw agricultural • Crop production (NAICS code 111). along with more information about commodities after harvest, on animals, • Animal production (NAICS code 112). dockets generally, is available at http:// and in antimicrobial formulations (food- • Food manufacturing (NAICS code 311). www.epa.gov/dockets. • contact surface sanitizing solutions). Pesticide manufacturing (NAICS code II. Petition for Exemption Spring Trading Company, on behalf of 32532). Clariant Corporation, submitted a In the Federal Register of April 11, B. How can I get electronic access to 2018 (83 FR 15528) (FRL–9975–57), petition to EPA under the Federal Food, other related information? Drug, and Cosmetic Act (FFDCA), EPA issued a document pursuant to requesting establishment of an You may access a frequently updated FFDCA section 408, 21 U.S.C. 346a, exemption from the requirement of a electronic version of 40 CFR part 180 announcing the filing of a pesticide tolerance. This regulation eliminates the through the Government petition (PP IN–11074) by Spring need to establish a maximum Office’s e-CFR site at http:// Trading Company, 203 Dogwood Trail, www.ecfr.gov/cgi-bin/text-idx?& Magnolia, TX 77354, on behalf of permissible level for residues of waxes _ and waxy substances, rice bran, c=ecfr&tpl=/ecfrbrowse/Title40/40tab Clariant Corporation. The petition oxidized in accordance with the terms 02.tpl. requested that 40 CFR 180.910, 180.930, and 180.940(a) be amended by of the exemptions. C. How can I file an objection or hearing establishing an exemption from the request? DATES: This regulation is effective requirement of a tolerance for residues February 26, 2019. Objections and Under FFDCA section 408(g), 21 of waxes and waxy substances, rice requests for hearings must be received U.S.C. 346a, any person may file an bran, oxidized (CAS Reg. No. 1883583– on or before April 29, 2019, and must objection to any aspect of this regulation 80–9) (‘‘rice bran oxidized’’), when be filed in accordance with the and may also request a hearing on those used as an inert ingredient as a flow aid, instructions provided in 40 CFR part objections. You must file your objection surface protection, film-forming, carrier, 178 (see also Unit I.C. of the or request a hearing on this regulation coating agent, and adjuvant in pesticide SUPPLEMENTARY INFORMATION). in accordance with the instructions formulations applied on growing crops ADDRESSES: The docket for this action, provided in 40 CFR part 178. To ensure and raw agricultural commodities after identified by docket identification (ID) proper receipt by EPA, you must harvest, to animals, and in antimicrobial number EPA–HQ–OPP–2018–0032, is identify docket ID number EPA–HQ– formulations (food-contact surface available at http://www.regulations.gov OPP–2018–0032 in the subject line on sanitizing solutions). That document or at the Office of Pesticide Programs the first page of your submission. All referenced a summary of the petition Regulatory Public Docket (OPP Docket) objections and requests for a hearing prepared by Spring Trading Company in the Environmental Protection Agency must be in writing, and must be on behalf of Clariant Corporation, the Docket Center (EPA/DC), West William received by the Hearing Clerk on or petitioner, which is available in the Jefferson Clinton Bldg., Rm. 3334, 1301 before April 29, 2019. Addresses for docket, http://www.regulations.gov. One Constitution Ave. NW, Washington, DC mail and hand delivery of objections comment was received on the notice of 20460–0001. The Public Reading Room and hearing requests are provided in 40 filing. EPA’s response to these is open from 8:30 a.m. to 4:30 p.m., CFR 178.25(b). comments is discussed in Unit V.C. Monday through Friday, excluding legal In addition to filing an objection or holidays. The telephone number for the hearing request with the Hearing Clerk III. Inert Ingredient Definition Public Reading Room is (202) 566–1744, as described in 40 CFR part 178, please Inert ingredients are all ingredients and the telephone number for the OPP submit a copy of the filing (excluding that are not active ingredients as defined

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in 40 CFR 153.125 and include, but are occur as a result of pesticide use in Rice ban wax oxidized was shown to not limited to, the following types of residential settings. If EPA is able to have low acute oral toxicity. There were ingredients (except when they have a determine that a finite tolerance is not no acute dermal or inhalation studies pesticidal efficacy of their own): necessary to ensure that there is a submitted; however, dermal and eye Solvents such as alcohols and reasonable certainty that no harm will irritation studies showed the rice bran hydrocarbons; surfactants such as result from aggregate exposure to the wax oxidized was not an irritant. Rice polyoxyethylene polymers and fatty inert ingredient, an exemption from the bran wax oxidized was also not acids; carriers such as clay and requirement of a tolerance may be considered a skin sensitizer in related diatomaceous earth; thickeners such as established. studies. carrageenan and modified cellulose; Consistent with FFDCA section No endpoint of concern was wetting, spreading, and dispersing 408(c)(2)(A), and the factors specified in identified for any of the acute, agents; propellants in aerosol FFDCA section 408(c)(2)(B), EPA has subchronic, chronic, or reproductive/ dispensers; microencapsulating agents; reviewed the available scientific data developmental studies conducted at any and emulsifiers. The term ‘‘inert’’ is not and other relevant information in dose level including the limit dose of intended to imply nontoxicity; the support of this action. EPA has 1000 mg/kg/day. There was also no ingredient may or may not be sufficient data to assess the hazards of evidence of carcinogenicity in any of the chemically active. Generally, EPA has and to make a determination on studies including chronic studies and exempted inert ingredients from the aggregate exposure for rice bran wax studies on mutagenicity and requirement of a tolerance based on the oxidized including exposure resulting cytotoxicity. In addition, no low toxicity of the individual inert from the exemption established by this neuropathological changes or effects ingredients. action. EPA’s assessment of exposures were reported in any of the studies. There is also no indication in the IV. Aggregate Risk Assessment and and risks associated with rice bran wax database that rice bran wax oxidized Determination of Safety oxidized follows. will be immunotoxic. Section 408(c)(2)(A)(i) of FFDCA A. Toxicological Profile Furthermore, the potential for allows EPA to establish an exemption EPA has evaluated the available absorption of rice bran wax via the from the requirement for a tolerance (the toxicity data and considered their gastrointestinal (GI) tract is limited. The legal limit for a pesticide chemical validity, completeness, and reliability as long-chain esters present in residue in or on a food) only if EPA plant-based waxes are generally thought determines that the tolerance is ‘‘safe.’’ well as the relationship of the results of the studies to human risk. EPA has also to be poorly absorbed in the GI tract as Section 408(c)(2)(A)(ii) of FFDCA uptake is thought to decrease as chain defines ‘‘safe’’ to mean that ‘‘there is a considered available information concerning the variability of the length and hydrophobicity increase. reasonable certainty that no harm will Rice bran wax is being used as a result from aggregate exposure to the sensitivities of major identifiable subgroups of consumers, including surrogate for rice bran wax oxidized pesticide chemical residue, including based on its similar physical and all anticipated dietary exposures and all infants and children. Specific information on the studies received and chemical properties and expected other exposures for which there is potential for toxicity. Similar to rice reliable information.’’ This includes the nature of the adverse effects caused by rice bran wax oxidized, as well as the bran wax, which is poorly absorbed, it exposure through drinking water and in is unlikely that rice bran wax oxidized residential settings, but does not include no-observed-adverse-effect-level (NOAEL) and the lowest-observed- would be systemically available for GI occupational exposure. Section absorption, as both substance are 408(c)(2) requires EPA to take into adverse-effect-level (LOAEL) from the toxicity studies are discussed in this comprised of very long carbon chain account the factors specified in lengths which are not absorbed. subparagraphs (b)(2)(C) and (D) in unit. making this safety determination. Available studies on rice bran wax B. Toxicological Points of Departure/ Section 408(b)(2)(C) of FFDCA requires oxidized include an acute oral toxicity Levels of Concern EPA to give special consideration to study, a dermal irritation study, an eye Available toxicity studies on rice bran exposure of infants and children to the irritation study, a dermal sensitization wax oxidized indicate that it has a very pesticide chemical residue in study, and an Ames assay. No low acute, subchronic, and chronic establishing a tolerance and to ‘‘ensure subchronic or chronic studies are toxicity. No adverse effects were seen in that there is a reasonable certainty that available for rice bran wax oxidized. any of the studies presented at the limit no harm will result to infants and Because data on rice bran wax oxidized dose of 1000 mg/kg/day; therefore, no children from aggregate exposure to the is limited, surrogate data on various endpoint of concern has been identified pesticide chemical residue . . . .’’ other long chain fatty acids, long chain for acute, subchronic, or chronic EPA establishes exemptions from the fatty alcohols, and long chain fatty toxicity. requirement of a tolerance only in those esters were used to support the safety cases where it can be clearly finding for rice bran wax oxidized as C. Exposure Assessment demonstrated that the risks from rice bran wax oxidized is a natural 1. Dietary exposure from food and aggregate exposure to pesticide substance comprised predominantly of feed uses. In evaluating dietary chemical residues under reasonably long chain fatty acids, long chain fatty exposure to rice bran wax oxidized, EPA foreseeable circumstances will pose no alcohols, and long chain fatty esters. considered exposure under the appreciable risks to human health. In Submitted data consisted of numerous proposed exemption from the order to determine the risks from subchronic, chronic, and reproductive/ requirement of a tolerance and other aggregate exposure to pesticide inert developmental studies on substances natural sources of rice bran wax. EPA ingredients, the Agency considers the including , rice bran wax, assessed dietary exposures from rice toxicity of the inert in conjunction with a mixture of long chain bran wax oxidized in food as follows: possible exposure to residues of the alcohols, a mixture of sugar cane wax Dietary exposure to rice bran wax inert ingredient through food, drinking fatty acids, docosanol, docosanoic acid, oxidized may occur from eating foods water, and through other exposures that and policosanol. naturally containing rice bran wax

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(which is metabolized by the body to oxidized which does not use safety adjuvant) in pesticide formulations rice bran wax oxidized) and foods factors for assessing risk, and no applied to growing crops and raw treated with pesticide formulations additional safety factor is needed for agricultural commodities after harvest, containing rice bran wax oxidized as an assessing risk to infants and children. to animals, and in antimicrobial inert ingredient. Because no formulations (food-contact surface E. Aggregate Risks and Determination of toxicological endpoint of concern was sanitizing solutions). Safety identified for rice bran wax oxidized, a VII. Statutory and Executive Order quantitative dietary exposure Taking into consideration all available Reviews assessment for rice bran wax oxidized information on rice bran wax oxidized, was not conducted. EPA has determined that there is a This action establishes an exemption 2. Dietary exposure from drinking reasonable certainty that no harm to any from the requirement of a tolerance water. Although drinking water population subgroup will result from under FFDCA section 408(d) in exposures from use of pesticide aggregate exposure to rice bran wax response to a petition submitted to the formulations containing rice bran wax oxidized under reasonably foreseeable Agency. The Office of Management and oxidized on food crops is possible, an circumstances. Therefore, the Budget (OMB) has exempted these types endpoint of concern was not identified establishment of exemptions from the of actions from review under Executive for the acute or chronic dietary requirement of a tolerance under 40 CFR Order 12866, entitled ‘‘Regulatory assessment; therefore, a quantitative 180.910, 180.930, and 180.940(a) for Planning and Review’’ (58 FR 51735, dietary exposure risk assessment for residues of waxes and waxy substances, October 4, 1993). Because this action drinking water was not conducted. rice bran, oxidized when used as an has been exempted from review under 3. From non-dietary exposure. The inert ingredient in pesticide Executive Order 12866, this action is term ‘‘residential exposure’’ is used in formulations applied pre- and post- not subject to Executive Order 13211, this document to refer to non- harvest, on animals, and in entitled ‘‘Actions Concerning occupational, non-dietary exposure antimicrobial formulations (food-contact Regulations That Significantly Affect (e.g., textiles (clothing and diapers), surface sanitizing solutions), is safe Energy Supply, Distribution, or Use’’ (66 carpets, swimming pools, and hard under FFDCA section 408. FR 28355, May 22, 2001) or Executive surface disinfection on walls, floors, Order 13045, entitled ‘‘Protection of V. Other Considerations tables). Rice bran wax oxidized may be Children from Environmental Health used as inert ingredient in pesticide A. Analytical Enforcement Methodology Risks and Safety Risks’’ (62 FR 19885, products that are registered for specific An analytical method is not required April 23, 1997), nor is considered a uses that may result in indoor or for enforcement purposes since the regulatory action under Executive Order outdoor residential exposures. Since Agency is establishing an exemption 13771, entitled ‘‘Reducing Regulations there are no toxicological effects of from the requirement of a tolerance and Controlling Regulatory Costs’’ (82 concern at the limit dose in available without any numerical limitation. FR 9339, February 3, 2017). This action studies, a quantitative assessment of does not contain any information residential (non-occupational) B. Response to Comments collections subject to OMB approval exposures and risks is not necessary. One comment was received in under the Paperwork Reduction Act 4. Cumulative effects from substances response to the Notice of Filing, (PRA) (44 U.S.C. 3501 et seq.), nor does with a common mechanism of toxicity. generally stating that exposure to it require any special considerations Section 408(b)(2)(D)(v) of FFDCA unnecessary pesticides needs to be under Executive Order 12898, entitled requires that, when considering whether decreased. The Agency recognizes that ‘‘Federal Actions to Address to establish, modify, or revoke a some individuals believe that pesticides Environmental Justice in Minority tolerance, the Agency consider should be limited or banned on Populations and Low-Income ‘‘available information’’ concerning the agricultural crops. However, the existing Populations’’ (59 FR 7629, February 16, cumulative effects of a particular legal framework provided by section 1994). pesticide’s residues and ‘‘other 408 of the Federal Food, Drug and Since tolerances and exemptions that substances that have a common Cosmetic Act (FFDCA) states that are established on the basis of a petition mechanism of toxicity.’’ tolerances may be set when persons under FFDCA section 408(d), such as Rice bran wax oxidized does not have seeking such tolerances or exemptions the tolerance in this final rule, do not toxic mode of action and therefore, have demonstrated that the pesticide require the issuance of a proposed rule, cumulative risk assessment is not meets the safety standard imposed by the requirements of the Regulatory necessary. that statute. This citizen’s comment Flexibility Act (RFA) (5 U.S.C. 601 et appears to be directed at the underlying seq.), do not apply. D. Safety Factor for Infants and This action directly regulates growers, Children statute and not EPA’s implementation of it; the citizen has provided no food processors, food handlers, and food Section 408(b)(2)(C) requires EPA to information that would support a retailers, not States or tribes, nor does retain an additional tenfold margin of conclusion that these exemptions are this action alter the relationships or safety in the case of threshold effects to not safe. distribution of power and ensure that there is a reasonable responsibilities established by Congress certainty that no harm will result to VI. Conclusions in the preemption provisions of FFDCA infants and children from aggregate Therefore, exemptions from the section 408(n)(4). As such, the Agency exposure to the pesticide chemical requirement of a tolerance are has determined that this action will not residue. As noted in Unit IV.B., there is established under 40 CFR 180.910, have a substantial direct effect on States no indication of threshold effects being 180.930, and 180.940(a) for residues of or tribal governments, on the caused by rice bran wax oxidized at the waxes and waxy substances, rice bran, relationship between the national limit dose. Therefore, due to the lack of oxidized (CAS Reg. No. 1883583–80–9) government and the States or tribal any toxicological endpoints of concern when used as an inert ingredient (flow governments, or on the distribution of at the limit dose, EPA is conducting a aid, surface protectant, film-forming power and responsibilities among the qualitative assessment of rice bran wax agent, carrier, coating agent, or various levels of government or between

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the Federal Government and Indian VIII. Congressional Review Act Dated: December 21, 2018. tribes. Thus, the Agency has determined Donna Davis, that Executive Order 13132, entitled Pursuant to the Congressional Review Acting Director, Registration Division, Office ‘‘Federalism’’ (64 FR 43255, August 10, Act (5 U.S.C. 801 et seq.), EPA will of Pesticide Programs. 1999) and Executive Order 13175, submit a report containing this rule and Therefore, 40 CFR chapter I is entitled ‘‘Consultation and Coordination other required information to the U.S. amended as follows: with Indian Tribal Governments’’ (65 FR Senate, the U.S. House of 67249, November 9, 2000) do not apply Representatives, and the Comptroller PART 180—[AMENDED] to this action. In addition, this action General of the United States prior to ■ 1. The authority citation for part 180 does not impose any enforceable duty or publication of the rule in the Federal continues to read as follows: contain any unfunded mandate as Register. This action is not a ‘‘major described under Title II of the Unfunded rule’’ as defined by 5 U.S.C. 804(2). Authority: 21 U.S.C. 321(q), 346a and 371. Mandates Reform Act (UMRA) (2 U.S.C. List of Subjects in 40 CFR Part 180 ■ 2. In § 180.910, add alphabetically the 1501 et seq.). inert ingredient ‘‘Waxes and waxy This action does not involve any Environmental protection, substances, rice bran, oxidized (CAS technical standards that would require Administrative practice and procedure, Reg. No. 1883583–80–9)’’ to the table to Agency consideration of voluntary Agricultural commodities, Pesticides read as follows: consensus standards pursuant to section and pests, Reporting and recordkeeping requirements. § 180.910 Inert ingredients used pre- and 12(d) of the National Technology post-harvest; exemptions from the Transfer and Advancement Act requirement of a tolerance. (NTTAA) (15 U.S.C. 272 note). * * * * *

Inert ingredients Limits Uses

******* Waxes and waxy substances, rice bran, oxidized (CAS Reg...... Flow aid, surface protectant, film-forming agent, carrier, coat- No. 1883583–80–9). ing agent, or adjuvant.

*******

■ 3. In § 180.930, add alphabetically the Reg. No. 1883583–80–9)’’ to the table to § 180.930 Inert ingredients applied to inert ingredient ‘‘Waxes and waxy read as follows: animals; exemptions from the requirement substances, rice bran, oxidized (CAS of a tolerance. * * * * *

Inert ingredients Limits Uses

******* Waxes and waxy substances, rice bran, oxidized (CAS Reg...... Flow aid, surface protectant, film-forming agent, carrier, coat- No. 1883583–80–9). ing agent, or adjuvant.

*******

■ 4. In § 180.940(a), add alphabetically § 180.940 Tolerance exemptions for active (a) * * * the inert ingredient ‘‘Waxes and waxy and inert ingredients for use in substances, rice bran, oxidized’’ to the antimicrobial formulations (Food-contact table to read as follows: surface sanitizing solutions). * * * * *

Pesticide chemical CAS Reg. No. Limits

******* Waxes and waxy substances, rice bran, oxidized ...... 1883583–80–9 None.

*******

* * * * * [FR Doc. 2019–03295 Filed 2–25–19; 8:45 am] BILLING CODE 6560–50–P

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